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idebenone

Raxone · ATC code N06BX13

Also known as: Idebenon, İdebenon

Key facts
Active substance
idebenone
ATC code
N06BX13
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Raxone 150 mg film-coated tablets
Marketing authorisation holder
Chiesi Farmaceutici S.p.A
Information as of
2026-10-28

Key facts

Idebenone (Raxone) is a short-chain benzoquinone used to treat visual impairment in adolescents and adults with Leber's Hereditary Optic Neuropathy (LHON).

What it is used for

  • Treatment of visual impairment in adolescent and adult patients with Leber's Hereditary Optic Neuropathy (LHON).

Dosing

  • 900 mg/day (300 mg, 3 times a day).
  • Tablets are swallowed whole with water, not broken or chewed, and taken with food, which increases bioavailability.
  • Data on continuous treatment are available for up to 24 months.
  • No specific adjustment in the elderly; no posology recommendation can be made for hepatic or renal impairment, where caution is advised.
  • Safety and efficacy under 12 years have not been established.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients.

Important warnings

  • Caution in hepatic or renal impairment; adverse events in hepatic impairment have led to interruption or discontinuation.
  • Metabolites may cause harmless reddish-brown discoloration of the urine (chromaturia); this should not mask colour changes from other causes such as renal or blood disorders.
  • Contains lactose and sunset yellow (E110), which may cause allergic reactions.

Side effects

  • Very common: nasopharyngitis, cough.
  • Common: diarrhoea (usually mild to moderate), back pain.
  • Not known: bronchitis, blood disorders (agranulocytosis, anaemia, leukocytopenia, thrombocytopenia, neutropenia), seizure, delirium, hallucinations, nausea, vomiting.

Interactions

  • Idebenone is a mild CYP3A4 inhibitor in vivo: after repeated dosing, midazolam Cmax and AUC rose by 28% and 34%; CYP3A4 substrates with a narrow therapeutic index should be used with caution (see the full text).

Pregnancy and breastfeeding

  • In pregnancy, use only if the benefit outweighs any potential risk; idebenone is excreted in animal milk, so a decision on breast-feeding or therapy is required.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • RaxoneChiesi Farmaceutici S.p.A · EMEA/H/C/003834

Source: European Medicines Agency (EMA), product information

Turkey

  • IdebexNEUTEC İLAÇ SAN. TİC. A.Ş · 4 register entries

Source: TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, as of 2026-10-16

Brand names in 4 more European countries
Iceland
Raxone
Liechtenstein
Raxone
Norway
Raxone
Portugal
Amizal, Cerestabon, Idecortex

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

Another question about this substance?

Medelix answers clinical questions from guidelines, studies and product information – every claim with its source.

Sources

  1. European Medicines Agency. Raxone – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/raxone-epar-product-information_en.pdf
  2. TİTCK – Ruhsatlı Beşeri Tıbbi Ürünler Listesi, 2026-10-16. https://www.titck.gov.tr/dinamikmodul/85

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.